MRF-Guided Surgery for Brain Tumors

Overseen By Chaitra Badve, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Prior glioblastoma treatment, Recurrent glioma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new way to use MRI scans, called MR fingerprinting, to help doctors see brain tumors more clearly during surgery. The goal is to determine if this method can better show tumor spread compared to standard MRI images. Two groups participate: one undergoes surgery with regular MRI guidance, and the other uses the new MRF images for guidance. This trial may suit individuals with untreated brain tumors larger than 3 cm. As a Phase 1 trial, the research focuses on understanding how the new MRI method works in people, offering participants the chance to be among the first to benefit from this innovative imaging technique.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRF/MRI technique is safe for brain tumor surgery?

Research shows that using MR imaging during surgery is safe. Studies have found that complications are rare, and no negative effects link to the MR environment. This suggests that MR fingerprinting to guide surgery is generally well-tolerated. Additionally, past research indicates that MRI can greatly assist in planning and guiding brain surgeries, enhancing precision. While the evidence is promising, this research area remains new, so safety undergoes careful testing. However, early findings offer reassurance about the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRF-guided surgery technique for brain tumors because it offers a more precise way to guide surgeons during operations. Unlike the standard surgical care that relies primarily on the surgeon's direct view and conventional MRI scans, this method integrates advanced MRI and MRF analysis to provide detailed maps of tumor infiltration. This enhanced imaging has the potential to help surgeons remove more of the tumor while sparing healthy brain tissue, potentially improving patient outcomes and reducing recurrence rates.

What evidence suggests that MRF/MRI infiltration guidance is effective for brain tumor surgery?

Research has shown that MRI guidance during brain tumor surgery helps surgeons remove more of the tumor compared to traditional methods. In this trial, participants in Group 2 will undergo surgery with advanced MRI and MR fingerprinting (MRF) analysis, which may better identify the tumor's spread in the brain than regular MRI. This advanced imaging aids surgeons in making more informed decisions about tumor removal. Using MRI during surgery has often resulted in more extensive tumor removal; one study noted a 29.2% increase in these extended removals. Overall, these techniques aim to enhance the accuracy of brain tumor surgeries, potentially improving patient outcomes. ^{3 4 6 7 8}

Who Is on the Research Team?

Chaitra A Badve, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Tiffany Hodges, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with glioblastoma, a type of brain tumor. Participants should be eligible for neurosurgical resection, the surgical removal of part of the brain to treat their condition.

Inclusion Criteria

Ability to provide written informed consent

I am older than 18.

MR imaging findings suggestive of GB

Exclusion Criteria

I cannot undergo surgery due to health risks.

Contraindications to MRI

I had a minor surgery or biopsy for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgical resection of glioblastomas with or without advanced MRI and MRF analysis guidance

1 day

1 visit (in-person)

Immediate Post-Surgery Monitoring

Participants are monitored for serious adverse events 48 hours post-surgery

48 hours

Short-term Follow-up

Participants are monitored for serious adverse events 30 days post-surgery

30 days

Long-term Follow-up

Participants are monitored for progression-free survival and recurrence

12 months

What Are the Treatments Tested in This Trial?

Interventions

• MRF/MRI infiltration guidance for extended resection

Trial Overview

The study is testing if Magnetic Resonance Fingerprinting (MRF) can better guide surgeons in removing more of the brain tumor than standard MRI techniques during surgery.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

The surgeon will have access to advanced MRI and MRF analysis research images during surgery and may use them for guidance, in addition to all routinely used surgical tools.

Group II: Group 1 Experimental Treatment 1 Intervention

Routine standard of care process will be followed for neurosurgical guidance

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Recent advancements in magnetic resonance (MR) technology have led to stronger magnetic fields and improved safety features, but most MR-related injuries and fatalities are due to non-compliance with safety guidelines.

To enhance safety in MR environments, it is crucial to update and revise safety information regarding biological effects and the compatibility of biomedical implants and devices with current MR technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. Shellock, FG., Crues, JV.[2008]

Intraoperative magnetic resonance (MR) imaging significantly aided in achieving complete tumor resection, with 80% of patients showing radiologically complete resections based on intraoperative findings.

The use of MR imaging during surgery was safe, with a low frequency of complications and no adverse effects related to the MR environment, highlighting its potential benefits in brain tumor surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain tumor resection: intraoperative monitoring with high-field-strength MR imaging-initial results. Martin, AJ., Hall, WA., Liu, H., et al.[2004]

Citations

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withpower.com/trial/phase-1-glioblastoma-11-2024-b48c2

MRF-Guided Surgery for Brain Tumors

Research shows that using MRI guidance during brain tumor surgery helps surgeons remove more of the tumor compared to traditional methods. This approach has ...

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Comparing Utility of Intraoperative Magnetic Resonance...

Can MR fingerprinting, a new way of acquiring MRI images, help identify the extent of tumor spread in the brain, better than routine MRI images? Patients with ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12182469/

Advances of MR imaging in glioma: what the neurosurgeon ...

This review highlights how advanced MRI techniques can inform clinical decision-making at each stage of care in patients with high-grade gliomas.

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thejns.org

thejns.org/view/journals/j-neurosurg/142/5/article-p1319.xml

Efficacy and safety of intraoperative MRI in glioma surgery

Intraoperative MRI led to extended glioma resections in 29.2% of the investigated pooled data, aligning with rates from other studies: 35.2% in ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12560701/

A Systematic Review and Meta-Analysis - PubMed Central - NIH

Can MR fingerprinting, a new way of acquiring MRI images, help identify the extent of tumor spread in the brain, better than routine MRI images?

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06455189

Magnetic Resonance Fingerprinting Guided Extended ...

The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6457761/

Image guided surgery for the resection of brain tumours - PMC

We found low quality evidence that using image guided surgery can lead to more of the tumour being removed surgically in some people. It has not been proven ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0361923025003454

Advanced imaging and localization techniques in brain ...

Overall, MRI not only supports meticulous preoperative planning but also plays a crucial role in intraoperative guidance and postoperative ...